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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Cas Number:
- 139734-65-9
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Amines, N-C10–C16-alkyltrimethylenedi-, reaction products with chloroacetic acid
- Details on test material:
- - Name of test material: DOPA-Glycinate
Constituent 1
Method
- Target gene:
- his operon (Salmonella strains), trp operon (E. coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : rat liver
- method of preparation of S9 mix: according to Ames et al. (1975) and Maron and Ames (1983): Male Wistar rats were injected intraperitoeally with a single dose of Aroclor 1254 in soya bean oil. Five days after injection the livers were removed S9 was prepared.
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL S9 mix
- quality controls of S9: protein content, cytochrome P-450 content and sterility were checked - Test concentrations with justification for top dose:
- First assay: 0, 62, 185, 556, 1667 and 5000 µg/plate (in the presence and in the absence of rat liver S9 fraction)
Second assay: 0, 12.5, 25, 50, 100 and 200 µg/plate (in the presence and in the absence of rat liver S9 fraction) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Milli-Q-water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Solvent (Milli-Q-water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- ethylnitrosurea
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 - 72 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, background growth inhibition - Evaluation criteria:
- The mutagenicity study is considered valid if the mean colony counts of the control values of the strain are within acceptable ranges, if the results of the positive controls meet the criteria of positive response, and if no more than 5% of the plates are lost through contamination of other unforeseen events.
A test substance is considered to be positive in the bacterial reverse mutation test if the mean number of revertant colonies on the test plates is concentration-related increased or if a reproducible two-fold or more increase is observed compared to that on the negative control plates.
A test substance is considered to be negative in the bacterial reverse mutation test if it produces neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the test points.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Genotoxicity
Without metabolic activation: test item dissolved in Milli-Q-water did not cause a two-fold or more increase in the mean number of revertant colonies in all tested strains compared to the background spontaneous reversion rate in the negative control.
The mean number of revertant colonies in the negative controls was within the range of the historical controls.
Positive controls significantly increased the reverse mutation rate.
The results are presented in Table A6.6.1- 1and Table A6.6.1- 2.
With metabolic activation: test item dissolved in Milli-Q-water did not cause a two-fold or more increase in the mean number of revertant colonies in all tested strains compared to the background spontaneous reversion rate in the negative control.
The mean number of revertant colonies in the negative controls was within the range of the historical controls
Positive controls significantly increased the reverse mutation rate.
The results are presented in Table A6.6.1- 1 and Table A6.6.1- 2.
Cytotoxicity
Yes
In the first assay cytotoxicity was observed at and above 185 µg/plate with and without metabolic activation in all tested strains.
In the second assay, cytotoxicity was observed at 200 µg in the absence and presence of S9-mix, except for TA 1535 and TA 100 where normal growth was observed with S9 mix. At 100 µg per plate pin points were observed in TA 1537 and TA 98, in the absence of S9-mix.
The results are presented in Table A6.6.1- 1 and Table A6.6.1- 2.
Any other information on results incl. tables
Table A6.6.1 -1:First assay: average numbers of revertants per plate in E.coli or S.typhimurium after treatment with the test item (plate-incorporation assay, triplicate plates per concentration).
Concentration [µg/plate] |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E.coli |
Comments |
|||||
–S9 |
+S9 |
–S9 |
+S9 |
–S9 |
+S9 |
–S9 |
+S9 |
–S9 |
+S9 |
||
Control (mean number of revertant colonies) |
26±3 |
28±5 |
23±1 |
17±7 |
47±6 |
69±4 |
191±15 |
167±12 |
33±6 |
37±6 |
|
62 |
27±3 |
21±6 |
16±8 |
23±8 |
27±4 |
67±15 |
162±19 |
173±21 |
34±3 |
40±6 |
|
185 |
– |
17±2 |
– |
8±5 |
– |
11±1 |
– |
107±4 |
30±6 |
37±6 |
Cytotoxicity |
556 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
Cytotoxicity |
1667 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cytotoxicity |
5000 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Cytotoxicity |
Positive controls |
606±42 |
814±114 |
4087±1344 |
288±10 |
2219±82 |
1953±83 |
775±58 |
2879±186 |
222±10 |
1527±167 |
|
– plate not counted due to contamination or pin points |
Table A6.6.1-2:Second assay:average numbers of revertants per plate in E.coli or S.typhimurium after treatment with the test item (plate-incorporation assay, triplicate plates per concentration).
Concentration [µg/plate] |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
E.coli |
Comments |
|||||
–S9 |
+S9 |
–S9 |
+S9 |
–S9 |
+S9 |
–S9 |
+S9 |
–S9 |
+S9 |
||
Control (mean number of revertant colonies) |
24 |
29 |
18 |
26 |
42 |
68 |
184 |
173 ±17 |
47 |
48 |
|
12.5 |
30 |
23 |
19 |
27 |
41 |
69 |
168 |
162 |
49 |
64 |
|
25 |
24 |
18 |
16 |
21 |
32 |
52 |
172 |
144 |
37 |
44 |
|
50 |
25 |
18 |
18 |
29 |
41 |
55 |
187 |
179 |
40 |
44 |
|
100 |
25 |
23 |
– |
30 |
- |
51 |
164 |
179 |
51 |
47 |
Cytotoxicity (pin points observed in TA 1537; TA 98 without S9 mix) |
200 |
– |
121 |
– |
– |
– |
– |
– |
159 |
– |
– |
Cytotoxicity, (except TA 1535 and TA 100 with S9 mix) |
Positive controls |
721 |
500 |
2396 |
316 |
1314 |
845 |
856 |
2205 |
174 |
1695 |
|
– plate not counted due to pin points |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The registration substance was not mutagenic in this bacterial reverse mutation assay in the absence and presence of metabolic activation (S9 mix). - Executive summary:
The mutagenic potential of the registration substance (99.4% a.i.) was tested in the bacterial reverse mutation test using the plate incorporation assay. The study was conducted according to OECD guideline 471 (1997).
Two independent plate incorporation assays were performed at concentrations of up to 5000 µg per plate (first assay) or up to 200 µg/plate (second assay). In the first assay cytotoxicity was observed at ≥ 185 µg/plate ± S9 mix in all tested strains. In the second assay, cytotoxicity was observed at 200 µg ± S9 mix in all strains except for TA 1535 and TA 100.
No increase in the number of revertant colonies was found in any of the tested strains with or without metabolic activation while the positive controls gave the expected increase in the mean number of revertant colonies.
Under the conditions of this study, the test item dissolved in water was not mutagenic.
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